Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT01019694
Last Updated: 2014-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
470 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combivent Respimat 20/100 microgram(mcg)
patient to take 1 inhalation 4 times a day
Combivent Respimat 20/100 mcg
Open label randomized parallel
Combivent CFC-MDI 36/206 microgram-mcg
patient to take 2 inhalations 4 times a day
Combivent CFC-MDI
36/206 mcg Four times a day (QID)
Atrovent HFA 42 mcg + Albuterol HFA
patient to take 2 inhalations of each 4 times a day
Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
Open label randomized parallel
Interventions
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Combivent CFC-MDI
36/206 mcg Four times a day (QID)
Combivent Respimat 20/100 mcg
Open label randomized parallel
Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
Open label randomized parallel
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients 40 years of age or older.
3. Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack
4. All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) \< 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x \[height (inches) / 39.37\]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \[height (inches) / 39.37\]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x \[height (meters)\] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x \[height (meters)\] - 0.025 x age (years) - 2.60
5. Patients must be able to perform all study related procedures and maintain study records during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
Exclusion Criteria
2. Patients with a recent history (i.e., one year or less) of myocardial infarction.
3. Patients who have been hospitalized or being treated for heart failure within the past year.
4. Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year.
5. Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed).
6. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
7. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
8. Patients with a current diagnosis of asthma.
9. Patients with a history of significant alcohol or drug abuse.
10. Patients with known active tuberculosis.
11. Patients using beta blocker medications are excluded. Cardioselective beta blockers are allowed with caution. Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed.
12. Patients who regularly use daytime oxygen therapy for more than 1 hour per day Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed).
13. Patients using oral corticosteroid medication at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, except as required for treatment of exacerbation during the study.
14. Pregnant or nursing women.
15. Women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a medically approved means of contraception. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
16. Patients with known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride (BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components.
17. Previous participation in this study. (The patient cannot re-enroll into this study.)
18. Patients who are currently participating in another interventional study.
19. Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening.
20. Patients currently in any pulmonary rehabilitation program or scheduled to participate in any such program during the study period.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1012.62.153 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
1012.62.145 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1012.62.156 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1012.62.135 Boehringer Ingelheim Investigational Site
Berkeley, California, United States
1012.62.141 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1012.62.155 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
1012.62.126 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
1012.62.131 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1012.62.144 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
1012.62.123 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
1012.62.114 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1012.62.124 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1012.62.139 Boehringer Ingelheim Investigational Site
Pensacola, Florida, United States
1012.62.134 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1012.62.115 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
1012.62.146 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1012.62.113 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1012.62.157 Boehringer Ingelheim Investigational Site
Dubuque, Iowa, United States
1012.62.159 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
1012.62.116 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
1012.62.148 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1012.62.137 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1012.62.132 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
1012.62.117 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
1012.62.158 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
1012.62.127 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1012.62.129 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1012.62.147 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
1012.62.149 Boehringer Ingelheim Investigational Site
Summit, New Jersey, United States
1012.62.112 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
1012.62.111 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
1012.62.107 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1012.62.120 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1012.62.150 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
1012.62.103 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1012.62.104 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1012.62.154 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
1012.62.128 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1012.62.130 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1012.62.151 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1012.62.161 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1012.62.109 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1012.62.118 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1012.62.125 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1012.62.140 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1012.62.143 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1012.62.152 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1012.62.102 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1012.62.122 Boehringer Ingelheim Investigational Site
Danville, Virginia, United States
1012.62.119 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1012.62.142 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1012.62.108 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1012.62.133 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1012.62.105 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
1012.62.101 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia, United States
Countries
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References
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Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.
Other Identifiers
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1012.62
Identifier Type: -
Identifier Source: org_study_id
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